Spermicidal Efficacy Of A Vaginal Gel

Contraception Clinical Trial

Official title: A Pilot Descriptive Study On The Spermicidal Efficacy Of A Vaginal Gel Containing Or Not Sodium Lauryl Sulfate In Healthy Women And Their Male Partners

Status Completed

Clinical Trial Summary

There is an urgent need to develop non-hormonal innovative preventive measures under the control of women that can prevent unintended pregnancy. Based on our experimental data, the use of a gel formulation containing SLS could represent a potent and safe topical vaginal spermicide. The impact of such a preventive tool on public health will be enormous. After successfully completing supportive Phase I/II safety trials, the next step is a prospective pilot clinical trial to evaluate the safety and effectiveness of our gel formulation as a spermicidal agent and for preventing unintended pregnancy in healthy women.

Clinical Trial Description

Study objectives (Outcomes):

The primary objective (Primary outcome) of this clinical trial is to evaluate the spermicidal efficacy in vitro and in post-coital test of gel formulation containing or not 2% SLS, when applied once intravaginally in healthy volunteers (women with their stable male sexual partners).

The secondary objective (Secondary outcome) of the study is to evaluate the safety and preliminary efficacy in preventing pregnancy of the gel formulation containing 2% SLS when used repeatedly before each sexual intercourse for a period of 3 months.

Study design: Pilot trial First phase- During volunteers screening for eligibility, male sexual partners will submit sperm samples; half of the sperm sample will be used for spermogram, and the other half of the sperm sample will be used (if normal spermogram) for in vitro testing of the spermicidal efficacy of the gel formulation components. If eligible, the man and his eligible female sex partner will be enrolled. Eligible women of the eligible male sex partners will have one vaginal gel application up to 30 min before planned sexual intercourse (vaginal penile penetration) with male ejaculating inside the vagina. Women will come to the clinic within a maximum of 12h period after the sexual intercourse for post-coital test. The gel must not be applied during menstrual period. The use of other vaginal products and male condom by participants is prohibited during the study period. A diary will be given to participants to record information concerning the internal use, if any, of any vaginal product (including tampons). This pilot trial will be performed in 1 center at the facilities of the Clinical Research of the CHU de Québec-Université Laval, CHUL.

Second phase- Couples agreeing to use the product repeatedly will continue to use the gel-SLS before each and every sexual intercourse, except during menstruation, for a period of 3 months. Women will report safety parameters after each vaginal use of the gel-SLS and will be followed regularly at the facilities of the Clinical Research of the CHU de Québec-Université Laval, CHUL. ;

Related Conditions & MeSH terms

• Contraception

• NCT number: NCT03833115
• Study type: Interventional
• Source: Laval University
• Status: Completed
• Phase: N/A
• Start date: February 23, 2018
• Completion date: December 4, 2020